Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors (CRUCIAL)

• ClinicalTrials.gov Identifier: NCT00407537
• Recruitment Status: Completed
• First Posted: December 5, 2006
• Results First Posted: November 11, 2011
• Last Update Posted: July 23, 2015
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: December 1, 2006
• First Posted Date: December 5, 2006
• Results First Submitted Date: October 6, 2010
• Results First Posted Date: November 11, 2011
• Last Update Posted Date: July 23, 2015
• Study Start Date: March 2007
• Actual Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 5, 2011)

Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12 [ Time Frame: Baseline, Month 12 ]

Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated at the end of study treatment (Month 12).

• Original Primary Outcome Measures (submitted: December 4, 2006): The primary efficacy endpoint is the 10-year risk of developing total coronary heart disease using the Framingham Model at the end of 12 months.
• Change History: Complete list of historical versions of study NCT00407537 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: October 5, 2011)

• Framingham 10-year Risk of Total CHD at Month 4 [ Time Frame: Baseline, Month 4 ]
  Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated after 4 months of treatment (Month 4).
• European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12 [ Time Frame: Baseline, Month 12 ]
  European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 12 months of study treatment (Month 12).
• European SCORE 10-year Risk of Fatal CVD at Month 4 [ Time Frame: Baseline, Month 4 ]
  European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 4 months of study treatment (Month 4).
• Framingham 10-year Risk of Stroke at Month 12 [ Time Frame: Baseline, Month 12 ]
  Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific "calibration factor" for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12).
• Framingham 10-year Risk of Stroke at Month 4 [ Time Frame: Baseline, Month 4 ]
  Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific "calibration factor" for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12).
• Change From Baseline in Framingham 10-year Risk of Developing Total CHD [ Time Frame: Baseline, Month 4, Month 12 ]
  Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. Change from baseline calculated as mean at observation minus mean at Baseline.
• Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD [ Time Frame: Baseline, Month 4, Month 12 ]
  European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. Change from baseline calculated as mean at observation minus mean at Baseline.
• Mean Systolic and Diastolic Blood Pressure at Month 4 [ Time Frame: Month 4 ]
• Mean Systolic and Diastolic Blood Pressure at Month 12 [ Time Frame: Month 12 ]
• Change From Baseline in Systolic Blood Pressure (SBP) at Month 4 [ Time Frame: Baseline, Month 4 ]
• Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4 [ Time Frame: Baseline, Month 4 ]
• Change From Baseline in SBP at Month 12 [ Time Frame: Baseline, Month 12 ]
• Change From Baseline in DBP at Month 12 [ Time Frame: Baseline, Month 12 ]
• Mean Lipid Parameters at Month 4 [ Time Frame: Month 4 ]
  Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
• Mean Lipid Parameters at Month 12 [ Time Frame: Month 12 ]
  Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
• Change From Baseline in Lipid Parameters at Month 4 [ Time Frame: Baseline, Month 4 ]
  Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. Change from baseline measured as mean at Month 4 minus mean at Baseline.
• Change From Baseline in Lipid Parameters at Month 12 [ Time Frame: Baseline, Month 12 ]
  Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
• Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months [ Time Frame: Month 4, Month 12 ]
  Goals set at <140/90 mmHg according to the seventh Joint National Committee (JNC) on prevention, detection, evaluation, and treatment of high blood pressure and <140/90 mm Hg or <130/80 mm Hg for diabetics ccording to the European Society of Cardiology (ESC) guidelines.
• Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months [ Time Frame: Month 4, Month 12 ]
  Goal set at <100 mg/dL according to the United States (US) National Cholesterol Education Program Adult Treatment Panel 3 and at <80 mg/dL according to the European (EU) Society of Cardiology guidelines.
• Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months [ Time Frame: Month 4, Month 12 ]
  Treatments indicative of prescribed medications other than study provided Caduet.
• Number of Participants With Increase of Treatment Dosages After 4 Months. [ Time Frame: Month 4 ]
  Treatments indicative of prescribed medications other than study provided Caduet.

Original Secondary Outcome Measures (submitted: December 4, 2006)

• 10-year risk of developing total CHD using the Framingham Model at 4 months.
• 10-year risk of developing fatal CHD using the European SCORE model at 4 and 12 months.
• Blood pressure and lipid parameters at 4 and 12 months.
• 10 year risk of developing stroke using the Framingham model for stroke at 4 and 12 months.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors
• Official Title: A Cluster Randomized Trial On Cardiovascular Risk Factor Management: Caduet Versus Usual Care In Subjects With Hypertension And Additional Cardiovascular Risk Factors In Clinical Practice
• Brief Summary: To investigate whether a Caduet based treatment strategy might result in greater reduction in total cardiovascular risk as compared to usual care in subjects with hypertension and additional risk factors.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Hypertension
• Hypercholesterolemia

Intervention

Drug: Amlodipine besylate/atorvastatin calcium single pill combination

Open label amlodipine besylate/atorvastatin calcium single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion

Study Arms

Experimental: Caduet

Open label caduet added to usual care regimen followed by investigators.

Intervention: Drug: Amlodipine besylate/atorvastatin calcium single pill combination

Publications *

• Cho EJ, Kim JH, Sutradhar S, Yunis C, Westergaard M; CRUCIAL Trial Investigators. Proactive multifactorial intervention strategy reduces the risk of cardiovascular disease estimated with region-specific risk assessment models in Pacific Asian patients participating in the CRUCIAL trial. J Korean Med Sci. 2013 Dec;28(12):1741-8. doi: 10.3346/jkms.2013.28.12.1741. Epub 2013 Nov 26.
• Hradec J, Zamorano J, Sutradhar S. Post hoc analysis of the Cluster Randomized Usual Care versus Caduet Investigation Assessing Long-term risk (CRUCIAL) trial. Curr Med Res Opin. 2013 Jun;29(6):589-96. doi: 10.1185/03007995.2013.783795. Epub 2013 Apr 3.
• Kim JH, Zamorano J, Erdine S, Pavia A, Al-Khadra A, Sutradhar S, Yunis C; CR UCIAL Investigators. Proactive cardiovascular risk management versus usual care in patients with and without diabetes mellitus: CRUCIAL trial subanalysis. Postgrad Med. 2012 Jul;124(4):41-53. doi: 10.3810/pgm.2012.07.2565.
• Zamorano J, Erdine S, Pavia A, Kim JH, Al-Khadra A, Westergaard M, Sutradhar S, Yunis C; CRUCIAL Investigators. Proactive multiple cardiovascular risk factor management compared with usual care in patients with hypertension and additional risk factors: the CRUCIAL trial. Curr Med Res Opin. 2011 Apr;27(4):821-33. doi: 10.1185/03007995.2011.555754. Epub 2011 Feb 10.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 7, 2009): 1531
• Original Enrollment (submitted: December 4, 2006): 1968
• Actual Study Completion Date: October 2009
• Actual Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Hypertension with three additional risks factors (for example: smoking, type 2 diabetes, family history of early heart disease, history of stroke, age over 55 (men) and 65 (women)

Exclusion Criteria:

• Subjects currently receiving a statin or stopped statin within 6 months prior to enrollment.
• Subjects with a history of myocardial infarction and subjects with coronary bypass graft or intra-coronary interventions.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 35 Years to 79 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Costa Rica, Croatia, Czech Republic, Dominican Republic, Indonesia, Jordan, Korea, Republic of, Kuwait, Lebanon, Malaysia, Mexico, Panama, Philippines, Russian Federation, Saudi Arabia, Taiwan, Thailand, Turkey, United Arab Emirates, Venezuela

Administrative Information

• NCT Number: NCT00407537
• Other Study ID Numbers: A3841047
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: June 2015